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Zopiclone

This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.

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What is it?

Zopiclone (Zimovane®) is a type of sleeping tablet called a hypnotic that is sometimes prescribed for short periods of time to treat severe sleeping problems (insomnia). Whether you are pregnant or not, it is recommended that zopiclone is only used for short periods of time.

Is it safe to take zopiclone in pregnancy?

There is no yes or no answer to this question. When deciding whether or not to take zopiclone during pregnancy it is important to weigh up the benefits of its use against the known or possible risks, some of which will depend on how many weeks pregnant you are.

This leaflet summarises the scientific studies relating to the effects of zopiclone on a baby in the womb. It is advisable to consider this information before taking zopiclone if you are pregnant. For some women, treatment with zopiclone in pregnancy may be necessary.

Your doctor is the best person to help you decide what is right for you and your baby.

What if I have already taken zopiclone during pregnancy?

If you are taking any medicines it is always a good idea to let your doctor know that you are pregnant so that you can decide together whether you still need the medicines that you are on and to make sure that you are taking the lowest dose that works.

A small amount of scientific research suggests that zopiclone use in pregnancy might increase the chance of preterm delivery, low birth weight, and withdrawal symptoms in the baby at birth. These effects are likely to depend on when in pregnancy you took zopiclone, how much you took, and for how long. Your doctor will be able to advise you about whether you or your baby need any additional monitoring or tests in pregnancy or after birth.

Can taking zopiclone in pregnancy cause my baby to be born with birth defects?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

Three studies of a total of 1,589 pregnant women taking zopiclone did not provide evidence that their babies had a higher chance of having a birth defect. Studies of pregnant women who took other medicines that are chemically similar to zopiclone have also not provided any convincing evidence of a link to having a baby with a birth defect.

Although these studies provide some reassurance, more information about women who have taken zopiclone during pregnancy is needed.

Can taking zopiclone in pregnancy cause miscarriage?

Studies that collectively include a small number of women taking zopiclone during early pregnancy do not suggest that they had a higher chance of miscarriage. However, large, well-designed studies of women who have taken zopiclone in early pregnancy are required to confirm this.

The only small study that has investigated this found that women who had taken zopiclone during pregnancy were more likely to give birth early (before 37 weeks of pregnancy) than women who hadn’t. Use in pregnancy of medicines that are chemically related to zopiclone has also been shown to increase the chance of preterm birth.

Can taking zopiclone in pregnancy cause low birth weight?

The only small study that has investigated this found that women who had taken zopiclone during pregnancy were no more likely to have a baby with a low birth weight (<2,500 g) than women who hadn’t taken zopiclone. However, some (but not all) studies of women taking medicines related to zopiclone during pregnancy have linked their use to having a baby with a low birth weight (<2,500g). However, this may be because more babies born to women who take these medicines are born earlier (babies born early are generally smaller). There is no scientific proof that zopiclone affects a baby’s growth in the womb.

Can taking zopiclone in pregnancy cause stillbirth?

Studies that included a small number of women who took zopiclone during pregnancy overall did not suggest any concerning findings relating to their chance of stillbirth. However, large, well designed studies of women who have taken zopiclone in pregnancy are required before this can be confirmed.

Can taking zopiclone in pregnancy cause other health problems in the child?

Withdrawal symptoms at birth (‘neonatal withdrawal’)Withdrawal symptoms are thought to occur when the newborn baby’s body has to adapt to no longer getting certain types of medicines through the placenta.

There is currently no scientific information as to whether taking zopiclone in pregnancy could specifically cause a baby to experience withdrawal symptoms. However, one small study showed that newborn babies exposed in the womb to zopiclone did not have a higher chance of being treated in intensive care compared to unexposed newborn babies.

Because zopiclone is similar to other medicines that are known to cause neonatal withdrawal, close monitoring of your baby for a few days after birth may be advised if you have taken zopiclone regularly in the weeks before delivery.

Learning and behavioural problemsA baby’s brain continues to develop right up until the end of pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

No studies have been carried out to look at whether there is an increased risk of learning and behavioural problems in children who were exposed to zopiclone while in the womb.

Will my baby need extra monitoring?

As part of their routine antenatal care, most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects and to check the baby’s growth.

Your obstetrician may wish to monitor your baby’s growth more closely if you have taken zopiclone during pregnancy. Additionally, if you have taken zopiclone around the time of delivery, because of the risk of withdrawal symptoms in the baby, he/she may require extra monitoring after birth.

Are there any risks to my baby if the father has taken zopiclone?

We would not expect any increased risk to your baby if its father took zopiclone before or around the time you became pregnant.

Who can I talk to if I have questions?

If you have any questions regarding the information in this leaflet please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org.

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WE NEED YOUR HELP! Do you have 3 minutes to complete a short, quick and simple 12 question user feedback form about our bumps information leaflets? To have your say on how we can improve our website and the information we provide please visit www.surveymonkey.co.uk/r/uktis-bumps.

General information

Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks. They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.

Medicines use in pregnancy

Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby. There are, however, some medicines that can harm a baby’s normal development. How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.

If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.

When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.

Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider.It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.

www.medicinesinpregnancy.org

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.